Medtronic Orders Recall of Dangerous Defective Medical Devices
Written by James P. Nevin
The Food and Drug Administration has classified the recall of “some Medtronic devices used during heart procedures” as Class I, a category reserved for products with reasonable potential to cause serious injury or death. An estimated 15,000 devices made since April 2013 are affected by the recall.
The recalled devices are known as ‘guidewires’ – long thin wires – which are inserted through an artery and used to guide into place other devices such as stents. The coating – called polytetrafluoroethylene or PTFE – is intended to help wires slide more easily and has been found to be detaching from some wires which could potentially block a blood vessel.
The recall notice warned hospitals and distributors worldwide back in October, after Medtronic received reports of four issues related to the device. One included a patient who went into cardiac arrest but was resuscitated, company spokesman Joseph McGrath said. The Minneapolis based company said it has taken steps to prevent new shipments of the wires.
For more information regarding this recall, please visit the FDA Website which is updated regularly with information. Customers can also contact Medtronic Lifeline Technical Support directly by calling 1-877-526-7890 Monday through Friday, 8 AM through 5 PM Central Standard Time.
Sources: 1 & 2
